Effects of a Long-term Exercise Training Program on the Functional Capacity and Health-related Quality of Life in Inpatients With Psychotic Disorders

Обзор

Mental health represents a fundamental dimension of overall well-being, exerting a significant influence on mortality rates, health-related quality of life (HRQoL), levels of disability, and the strain on healthcare systems. As the interest in mental wellness continues to grow, exercise training (ET) has become increasingly recognized as a validated and effective intervention for individuals experiencing mental health challenges. An expanding body of research underscores the adverse effects of physical inactivity, reinforcing the role of exercise as a viable therapeutic strategy. Well-structured ET interventions have consistently demonstrated benefits across multiple domains, including improvements in physical health, reductions in cardiovascular risk, and enhancements in psychological constructs such as depression, self-esteem, resilience, and self-efficacy. However, the majority of prior studies have been limited to relatively short durations-typically ranging from 4 to 24 weeks, with an average of about 12 weeks. A significant gap in the literature persists regarding the long-term implementation and effectiveness of ET programs, particularly in populations with severe mental illness. Additionally, the small sample sizes commonly seen in previous studies restrict the statistical robustness and generalizability of their outcomes. The aim of the randomized control trial is to examine whether an 1-year mixed type exercise training program within the hospital setting will improve functional capacity and health-related quality of life. Forty- eight participants will be randomly allocated into two groups: Group A (Exercise group) will receive 3 exercise sessions per week for 1-year and Group B (Control Group) will continue their usual care, without participating in organized exercise programs. Prior to the group random allocation, part of the assessment at the baseline and 1 year follow-up will include lower extremity strength test, muscle power using a dynamometer, aerobic capacity test, balance test, body positioning and health- related quality of life.

Вмешательства

• Другое Exercise intervention
  Patients that will be randomly assigned in the group A will be invited to attent 1-year exercise sessions, with frequency 3 sessions per week. The program included 30 minutes of Pilates exercises, strengthening, balance and flexibility exercises, which are performed with rubber bands, mobility sticks and balls.

Первичные конечные точки

• Isometric Lower Extremity Strength Assessment in Semi-Squat Using Baseline Leg Dynamometer [Срок оценки: Baseline]
• Isometric Lower Extremity Strength Assessment in Semi-Squat Using Baseline Leg Dynamometer [Срок оценки: Follow-up assessment, 12 months post- baseline]
• Handgrip Strength [Срок оценки: Baseline]
• Handgrip Strength [Срок оценки: Follow-up assessment, 12 months post- baseline]
• Sit-and-Reach Test [Срок оценки: Baseline]
• Sit-and-Reach Test [Срок оценки: Follow-up assessment, 12 months post- baseline]
• 30 -second Sit-to-stand test (STS) [Срок оценки: Baseline]
• 30 -second Sit-to-stand test (STS) [Срок оценки: Follow-up assessment, 12 months post- baseline]
• Six- Minute Walking Test [Срок оценки: Baseline]
• Six- Minute Walking Test [Срок оценки: Follow-up assessment, 12 months post- baseline]

Критерии участия

Критерии включения

• being an adult
• inpatient with a diagnosis of psychotic syndrome
• on stable medication
• controlled as far as psychosis is concerned
• consenting to participate

Критерии исключения

• adolescents
• with other diagnoses
• not on stable medication
• in an unstable condition
• unwilling to participate in the study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Греция · 1 центр

• Sports Medicine Laboratory, Aristotle University of Thessaloniki — Thessaloniki

Идентификаторы

NCT: NCT07113119 · EH-44/2021

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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